Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Senior Clinical Research Associate (Senior Cra)

Navitas Lifesciences
Navitas lifesciences
3+ years
preferred by company
Bangalore, India
1 May 18, 2026
Job Description
Job Type: Full Time Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Senior Clinical Research Associate (Senior CRA)

Location: Bengaluru, India
Job Type: Full-Time
Work Mode: Onsite / Hybrid (As Per Business Requirement)
Industry: Clinical Research | CRO | Pharmaceutical | Life Sciences | Clinical Trials
Department: Clinical Research Operations
Experience Required: Minimum 3+ Years of Clinical Monitoring Experience (Freshers Not Eligible)
Employment Level: Associate / Mid-Senior Level

Job Overview

A growing clinical research organization is seeking an experienced Senior Clinical Research Associate (Senior CRA) to join its expanding clinical operations team in Bengaluru. This opportunity is ideal for professionals with strong expertise in clinical trial monitoring, site management, regulatory submissions, investigator coordination, GCP compliance, trial documentation management, and clinical operations execution.

The selected candidate will be responsible for overseeing site-level clinical trial activities, ensuring protocol compliance, supporting regulatory and project execution tasks, and maintaining strong communication with investigators, sponsors, vendors, and internal project teams.

This role is an excellent opportunity for professionals looking to grow in clinical operations, trial monitoring, site management, and sponsor-facing clinical research roles.

Key Responsibilities

Clinical Trial Start-Up & Study Set-Up

  • Conduct site feasibility assessments to evaluate study readiness and site suitability.
  • Support project start-up and study activation activities.
  • Perform site selection visits and qualification assessments.
  • Facilitate investigator and site contract negotiation and execution.
  • Develop and locally adapt study-specific documentation as per protocol and regulatory requirements.
  • Set up and maintain the Trial Master File (TMF).
  • Support regulatory submission activities and study initiation readiness.

Clinical Monitoring & Site Management

  • Conduct:
    • Site Initiation Visits (SIV)
    • Routine Site Monitoring Visits (SMV)
    • Site Close-Out Visits (COV)
  • Ensure studies are conducted in compliance with:
    • ICH E6 Good Clinical Practice (GCP) Guidelines
    • Local regulatory requirements
    • Internal Standard Operating Procedures (SOPs)
  • Monitor site performance, protocol compliance, subject safety, and data quality.
  • Maintain effective communication with investigators, coordinators, and study site teams.

Project Execution & Operational Support

  • Support end-to-end project conduct and clinical study execution.
  • Assist Project Managers (PM) and Project Team Leads (PTL) with study updates and operational progress tracking.
  • Participate in:
    • Investigator meetings
    • Sponsor/client meetings
    • Teleconferences
    • Internal cross-functional discussions
  • Act as backup communication support for client and vendor interactions where required.

Regulatory & Documentation Management

  • Facilitate regulatory documentation and submission support.
  • Ensure complete and compliant clinical trial documentation management.
  • Maintain and update TMF records throughout the study lifecycle.
  • Ensure audit-ready documentation standards are maintained.

Data Management & Query Resolution

  • Support Case Report Form (CRF) retrieval and reconciliation.
  • Ensure timely query turnaround and issue resolution with site teams.
  • Maintain data quality through proactive site communication and follow-up.

Issue Resolution & Escalation Management

  • Resolve site-level operational and compliance issues.
  • Escalate significant risks, delays, or compliance concerns to Project Managers when required.
  • Support risk mitigation and issue tracking.

Study Closeout Activities

  • Manage clinical trial closeout procedures.
  • Conduct site closeout visits and ensure proper documentation completion.
  • Support final reconciliation and study closure compliance.

Educational Qualification

Candidates must possess:

  • Bachelor’s Degree or higher in Life Sciences

Preferred educational backgrounds:

  • Clinical Research
  • Biotechnology
  • Pharmacy
  • Biomedical Sciences
  • Pharmacology
  • Life Sciences

Experience Requirements

  • Minimum 3+ years of clinical monitoring experience
  • Proven experience in:
    • Site monitoring
    • Clinical trial management
    • Investigator coordination
    • TMF management
    • Regulatory support activities
  • CRO or sponsor clinical monitoring experience preferred
  • Freshers are not eligible for this senior-level opportunity

Required Skills

  • Clinical Monitoring
  • Site Management
  • ICH E6 Good Clinical Practice (GCP)
  • Clinical Trial Operations
  • Trial Master File (TMF)
  • Site Initiation Visits (SIV)
  • Site Monitoring Visits (SMV)
  • Site Close-Out Visits (COV)
  • Regulatory Submission Support
  • Investigator Coordination
  • Feasibility Assessment
  • CRF Management
  • Query Resolution
  • Clinical Documentation
  • Risk Escalation Management
  • Vendor Coordination
  • Client Communication